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Geriatric Medicine

VIEWS: 20 PAGES: 58

									                           Evidence-Based Geriatric Medicine

Author:
Sharon E. Straus, MD, FRCP
                 University Health Network
                 Mount Sinai Hospital
                 Department of Medicine
                 University of Toronto

                                        Table of Contents
Ø Introduction to Evidence-Based Geriatric Medicine
Ø Other resources for Evidence-Based Geriatric Medicine
Ø Sample scenarios, searches, completed worksheets and CATs for Geriatric Medicine




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                      Introduction to Evidence-Based Geriatric Medicine

Can We Provide Evidence-Based Care for the Elderly?
Sharon E. Straus
EBM 1997;2(6):164 and ACP Journal Club 1997;127:A-19.

This question is becoming urgent as the population ages. In many developed countries, the proportion of
very elderly is already growing rapidly. From 1960 to 1990, the total US population grew by 39%, whereas
the number of persons aged 65 and older increased by 89%, and the number 85 years of age or older
increased by 232%1 . By 2010, the number of Canadian > 64 years is expected to increase by 45% and the
number > 85 by 125%2. This is partly because the oldest members of the baby-boom cohort will have
reached 65 years of age; 20 years later, they will join the oldest old (> 85 years). We need to assess and
optimize our health care for this group. Can we extend the practice of evidence-based medicine to the care
of the elderly? Is care of the elderly already evidence-based?




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A recent audit of a general medical team at a university-affiliated U.K. district hospital documented that >
80% of acute admissions (mean age 69 y, range 24 to 91 y) received evidence-based care3. No such audit
has been reported in the oldest old.
Elderly patients are less likely than younger patients to receive some specific treatments. Is this reluctance
evidence-based? Consider, for example, anticoagulation therapy for patients with chronic nonvalvular atrial
fibrillation (NVAF). Although 70% of individuals with AF are 65 to 85 years of age, the mean age of the
patients in the AF trials was 69 and only 20% were > 75 years of age4,5. These trials show that warfarin
reduces the risk of embolic stroke in patients with chronic NVAF, but it can also cause major hemorrhage4.
The elderly are at the highest risk for embolic stroke if not treated for NVAF and have the greatest absolute
risk reduction with treatment. However, the safety of anticoagulation therapy in the elderly is less certain.
The Stroke Prevention in Atrial Fibrillation (SPAF) II Study showed a rate of major hemorrhage of 4.2%/y in
patients 75 years of age compared with 1.7%/y in patients < 75 years of age6. A pooled analysis of 4 other
primary prevention trials found warfarin effective and relatively safe in persons > 75 years of age, with a risk
of intracranial hemorrhage of 0.3%/y7. The disparity may be because of a difference in anticoagulation
therapy management. The SPAF investigators found that intensity of anticoagulation therapy was an
independent risk factor for hemorrhage in the elderly; therefore, with careful management, we would hope
to decrease this risk6.


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Elderly patients with NVAF are less likely to be treated. 651 patients with NVAF at 2 community and 2
tertiary care hospitals were reviewed8. Although 609 of them had no contraindication to anticoagulation
therapy, 40% were not receiving prophylaxis – patients 45 to 54 years of age were twice as likely to receive
such therapy as patients 75 to 84. Similar results have been reported in hospital and outpatient settings9,10.
Is this disparity because clinicians believe the elderly are at an increased risk for hemorrhage or because
they feel the results cannot be applied to the elderly? Both explanations would benefit from the application
of one basic tenet of EBM: the integration of evidence with individual clinical expertise11. Clinicians of the
first sort might offer carefully managed anticoagulant therapy to elderly patients at low risk for major
hemorrhage, and clinicians of the second sort might reconsider whether their elderly patients are so unlike
the patients in the trials that the results do not apply.
This example highlights two important issues about our ability to practice EBM among the elderly. First, we
can do a better job of translating current evidence into practice; this includes quicker and easier access to
the evidence where it can be used. Second, we must push for better information about the risks and
benefits of interventions among the elderly, and stop excluding them from research will guide their care. We
do have evidence about some interventions in the elderly (e.g., geriatric assessment12 and the treatment of
hypertension13) and we know that certain interventions are most cost-effective in the elderly (tissue
plasminogen activator in acute myocardial infarction14). However, we remain relatively ignorant about many
of the needs of this population. Readers can encourage research on the elderly and encourage their elderly

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patients to participate in this research. In particular, we need to encourage the frail elderly (those with
complex medical and psychosocial problems) to participate in studies assessing interventions, prognosis
and quality of life.
In October 1997, > 100 medical journals worldwide were dedicated to the theme of aging. They have served
the second goal of encouraging research and thought on aging as well as including aging on scientific,
medical, social and political agendas15 It is hoped that this initiative will improve our ability to practice EBM
in the care of the elderly.


References
1      Bureau of the Census. Current population reports. Sixty-five plus in America. Washington, D.C.: Government Printing
       Office, 1993.
2      Partnerships in long-term health care. Toronto, Ontario: Ministry of Health, 1993.
3      Ellis J, Mulligan I, Rowe J, et al. Lancet 1995;346:407-10.
4      Atrial fibrillation Investigators. Arch Intern Med 1994;154:1449-57.
5      Feinberg WM, Blackshear JL, Laupacis A, et al. Arch Intern Med 1995;155:469-73.
6      The stroke prevention in atrial fibrillation investigators. Arch Intern Med 1996;156:409-16.


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7    Connolly S. Lancet 1994;343:1509.
 8   Munschauer FE, Priore RL, Hens MS, et al. Stroke 1997;28:72-76.
 9   Stafford RS, Singer DE. Arch Intern Med 1996;156:2537-41.
10   Gage BF, Boechler M, Flaker G, et al. J Gen Intern Med 1997;12(S1):71.
11   Sackett DL, Rosenberg WMC, Gray JAM, et al. BMJ 1996;312:71-2.
12   Stuck AE, Aronow HU, Steiner A, et al. N Engl J Med 1995;333:1184-9.
13   SHEP cooperative research group. JAMA 1991;265:3255-64.
14   Mark DB, Hlatky MA, Califf RM et al. N Engl J Med 1995;332:1418-24.
15   Rochon P, Smith R. BMJ 1996;313:1502.




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                     Other resources for Evidence-Based Geriatric Medicine

•   Best Evidence—includes many abstracts and commentaries relevant to the care of geriatric patients
•   Cochrane Dementia and Cognitive Impairment Group – URL http://www.jr2.ox.ac.uk/cdcig/ (it also has
    links to other websites which people might find useful)
•   Straus SE, Sackett DL. Practising Evidence-based geriatric medicine. A 7-session course for clinicians.
    Radcliffe Medical Press:Oxford, 1999. – this manual provides a completely self-contained course for
    clinicians at all levels of training to learn how to practise evidence-based geriatric medicine. It contains
    clinical scenarios, searches, copies of the primary articles, completed worksheets, CATs, and skill-
    training sessions in searching for evidence in the Cochrane Library, on the Internet, and with
    MEDLINE, and in running the CATmaker. Tutor’s and learners manuals are available through Radcliffe
    Medical Press 18 Marcham Road, Abingdon, Oxfordshire, England OX14 1AA; Phone: +44 (0)1235
    528830; Fax: +44 (0)1235 528830.




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Sample scenarios, searches, completed worksheets and CATs for Geriatric Medicine


A. DIAGNOSIS


Clinical Scenario


You admit a well 75 year old woman with community-acquired pneumonia. She responds nicely to
appropriate antibiotics but her haemoglobin remains at 100 g/l with a mean cell volume of 80. Her
peripheral blood smear shows hypochromia, she is otherwise well, and is on no incriminating medications.
You contact her GP and find out that her haemoglobin was 105 g/l 6 months ago. She has never been
investigated for anaemia. You discuss this patient with your registrar and debate the use of ferritin in the
diagnosis of iron deficiency anaemia. You admit to yourself that you are unsure how to interpret a ferritin
result and how precise and accurate a serum ferritin is for diagnosing iron deficiency anaemia.



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You therefore form the question, “In an elderly woman with hypochromic, microcytic anaemia, can a low
ferritin diagnose iron deficiency anaemia?” You order a ferritin and head for the library (10 days later it
comes back at 40 µg/l).


Searching Best Evidence on Disk with the single word “ferritin” yielded a very encouraging meta-analysis of
55 studies and a nice individual study, but your library didn’t carry either journal. You perform a MEDLINE
search using the MeSH terms “ferritin” and “sensitivity and specificity” and find an article on diagnosing iron
deficiency anaemia in the elderly published in a journal that your library does take (Am J Med 1990;88:205-
9).


Read this article and decide,
1. Are the results of this diagnostic article valid?
2. Are the valid results of this diagnostic study important?
3. Can you apply this valid, important evidence about a diagnostic test in caring for your patient?




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DIAGNOSIS WORKSHEET: page 1 of 2

Citation: Guyatt GH, Patterson C, Ali M, Singer J, Levine M, Turpie I, Meyer R: Diagnosis of iron-deficiency
anemia in the elderly. Am J Med 1990; 88: 205-9

               Are the results of this diagnostic study valid?
               1. Was there an independent, blind
                  comparison with a reference         Yes, they underwent bone-marrow
                  (“gold”) standard of diagnosis?     aspirations.


               2. Was the diagnostic test evaluated
                  in an appropriate spectrum of         Yes
                  patients (like those in whom it
                  would be used in practice)?


               3. Was the reference standard
                  applied regardless of the             Yes
                  diagnostic test result?




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Are the valid results of this diagnostic study important?

               FERRITIN                 IRON                      NO IRON                   Likelihood Ratio
                                        DEFICIENCY                DEFICIENCY
                    <45                      70/85                     15/150                          8.2
                  >45 <100                    7/85                     27/150                          0.44
                    >100                      8/85                    108/150                          0.13
               TOTALS                          85                       150

•   For pre-test probabilities in the 30-70% range, a ferritin <45 would be very helpful, yielding post-test
    probabilities of 78-95% (in the latter case, a SpPin1).
•   In that same pre-test probability range, a ferritin >100 would yield post-test probabilities of 5-23% (in the
    former case, a SnNout2 ).
•   So it can give quite important results.
1
       When a diagnostic test has a very high Specificity, a Positive result Rules-In the diagnosis.
2
       When a diagnostic test has a very high Sensitivity, a Negative result Rules-Out the diagnosis


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DIAGNOSIS WORKSHEET: page 2 of 2

Can you apply this valid, important evidence about a diagnostic test in caring for your patient?

               Is the diagnostic test available,
               affordable, accurate, and precise in     Needs to be assessed in each
               your setting?                            setting.




               Can you generate a clinically sensible
               estimate of your patient’s pre-test      Approximately 30%.
               probability (from practice data, from
               personal experience, from the report
               itself, or from clinical speculation).

               Will the resulting post-test             Her result of 40 brings her post-
               probabilities affect your management     test probability to 78%, certainly
               and help your patient? (Could it move    high enough for you to want to
               you across a test-treatment              investigate her for causes of
               threshold?; Would your patient be a      anaemia (GI loss, etc.).
               willing partner in carrying it out?)

               Would the consequences of the test       Yes, if it led to a reversible cause.
               help your patient?                       But this would have to be weighed
                                                        against early detection of an
                                                        untreatable cause (e.g., cancer)
                                                        that would simply take away
                                                        “healthy” time. The options would
                                                        need to be discussed with your
                                                        patient.

Additional Notes:
1. An excellent overview of 55 studies of lab tests for Fe-deficient anaemia: Guyatt et al: J Gen Intern Med
   1992;7:145-53 (with a correction on page 423).


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ANAEMIA: DIAGNOSIS OF IRON DEFICIENCY ANEMIA IN THE ELDERLY



Clinical Bottom Line
In community dwelling elderly medical patients in whom iron deficiency
anaemia is suspected, serum ferritin is a valid, precise diagnostic test.




Citation

Guyatt GH, Patterson CH, Ali M. Diagnosis of iron-deficiency anemia in the elderly. Am J Med 1990;
88:205-9.
Clinical Question: In a patient with anaemia can a low serum ferritin be used to diagnose iron deficiency?


Search terms: “ferritin” and “sensitivity and specificity” in MEDLINE

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The Study
1. Gold Standard - bone marrow aspiration
2. Study setting - consecutive pts over the age of 65 yr. who were admitted with anaemia to a university-
   affiliated hospital in Canada.

The Evidence

             FERRITIN             IRON                 NO IRON               LIKELIHOOD
                                  DEFICIENCY           DEFICIENCY            RATIO
                    <45                70/85                15/150                 8.2
                  >45<100               7/85                27/150                 0.44
                    >100                8/85               108/150                 0.13
                  TOTALS                 85                  150

Comments
1. Excluded patients from institutions and patients who were “too ill” or had “severe dementia” although
   these were not defined.

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2. Weighted kappa for bone marrow interpretation by 2 haematologists was 0.84.
3. Low values can SpPin, and high values can SnNout.
4. Also see the meta-analysis in J Gen Intern Med 1992;7:145-53. (with a correction on page 423).

Appraised by Straus, 1996, Reviewed 1998, Expiry date: 2000




B. PROGNOSIS


Clinical Scenario


You see a 70 year old man in an outpatient clinical 3 months after he has been discharged from your
service with an ischaemic (presumed thrombotic) stroke. He is in sinus rhythm, has mild residual left-sided
weakness but is otherwise well. His only medication is aspirin and he has no allergies. He recently saw an
article on the BMJ website describing the risk of seizure after a stroke and is concerned that this will happen

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to him. Together you form the question: “In patients with a history of stroke, what is the risk of seizure within
the first year?”

You search MEDLINE using the terms “stroke” and “seizure” and find the article he was referring to. (BMJ
1997;315:1582-7)


Read the article and decide,
1. Is this evidence about prognosis valid?
2. Is this valid evidence about prognosis important?
3. Can you apply this valid and important evidence about prognosis in caring for your patient?




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COMPLETED PROGNOSIS WORKSHEET:                  Page 1 of 2

Citation: Burn J, Dennis M, Bamford J et al. Epileptic seizures after a first stroke: the Oxfordshire
community stroke project. BMJ 1997;315:1582-7.

               Are the results of this prognosis study valid?
               1. Was a defined, representative       Yes - from a common point but
                  sample of patients assembled at a unsure how GPs decided which
                  common (usually early) point in the stroke patients should be admitted
                  course of their disease?            to hospital




               2. Was patient follow-up sufficiently    Yes-minimum of 2 years and up to
                  long and complete?                    6.5 years




               3. Were objective outcome criteria       Patients were asked at follow-up if
                  applied in a “blind” fashion?         they had a seizure and were then
                                                        assessed by a study neurologist
                                                        (unsure if neurologist was blinded)



               4. If subgroups with different         Looked at different stroke types,
                  prognoses are identified, was there previous history of stroke
                  adjustment for important prognostic
                  factors?




               5. Was there validation in an            No
                  independent group (“test-set”) of
                  patients?




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PROGNOSIS WORKSHEET:     Page 2 of 2



         Are the valid results of this prognosis study important?

         1. How likely are the outcomes over   5.7% over one year
            time?



         2. How precise are the prognostic     95% confidence interval - 3.5 to
            estimates?                         7.9%




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If you want to calculate a Confidence Interval around the measure of Prognosis:

         Clinical Measure                Standard Error (SE)             Typical calculation of CI
         Proportion (as in the rate of   √ {p x (1-p) / n}               If p = 24/60 = 0.4 (or 40%)
         some prognostic event,          where p is proportion and n     & n=60
         etc.) where:                    is number of patients
                                                                         SE=√{0.4 x (1-0.4) / 60} =
         the number of patients = n                                      0.063 (or 6.3%)

         the proportion of these                                         95% CI is 40% +/- 1.96 x
         patients who experience                                         6.3% or 27.6% to 52.4%
         the event = p

                                         √ {p x (1-p) / n}               Your calculation:
         n from your evidence: 675       where p is proportion and n
                                         is number of patients           SE: 0.009

         p from your evidence: 0.057                                     95% CI:5.7% +/- 1.7% =
                                                                         4% to 7.4%




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              Can you apply this valid, important evidence about prognosis in caring
              for your patient?

              1. Were the study patients similar to     Yes
                 your own?


              2. Will this evidence make a clinically   Yes
                 important impact on your
                 conclusions about what to offer or
                 tell your patient?

Additional Notes:




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Stroke-Risk of seizure

Clinical Bottom Line:
Stroke patients have a 5.7% risk of seizure at one year.


Citation: Burn J, Dennis M, Bamford J et al. Epileptic seizures after a first stroke: the Oxfordshire
community stroke project. BMJ 1997;315:1582-7.


Clinical Question: In a patient with stroke, what is the risk of seizure at one year?


Search Terms: “stroke” and “seizure” in Medline


The Study:

675 pts registered in a community-based stroke registry after their first stroke
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The Outcome: seizure

Well-defined sample at uniform (early) stage of illness..?, yes; Follow-up long enough..?, yes; Follow-up
complete..?, yes; Blind and objective outcome criteria..?, no; Adjustment for other prognostic factors..?, no;
Validation in an independent "test-set" of patients..?, no

The Evidence:

           Prognostic Factor               Outco      Time      Measure       Confidence
                                           me                                 Interval
           cerebral infarction             seizure    1 year    4.2%          2.2 to 6.2%
           primary intracerebral           seizure    1 year    20%%          1.5 to 38.3%
           haemorrhage
           subarachnoid haemorrhage        seizure    1 year    22%           2.6 to 41.8%
           any stroke                      seizure    1 year    5.7%          3.5 to 7.9%




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Comments:
1. Unsure how physicians selected patients for registration.
2. Onset seizures (those occurring within 24 hrs of onset of stroke) associated with increased risk of
   seizure - OR 7.52 (2.46 to 22.98).
3. Probability of post-stroke seizure higher among patients >84 (but numbers small).


Appraised by Straus, 1998; Expiry date: 2000




C. THERAPY


Clinical Scenario

You see a 75 year old patient referred to you by his GP because of raised blood pressure. His past medical
history is remarkable for mild asthma but he is otherwise well. His GP has enclosed a note stating that the
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patient’s blood pressure has been 160-190/80-90 for the past 3 months. The patient’s wife is on an ACE-I
and has had no adverse effects and the patient wondered if he could take it as well. You explain to the
patient that evidence from trials suggest that diuretics and beta blockers should be used as the initial
treatment strategy because they are known to decrease the risk of stroke. The patient asks to look at this
evidence with you. You formulate the question, “In patients with isolated systolic hypertension, do diuretics
decrease the risk of stroke and death?”

You start up Best Evidence, enter “hypertension” and “stroke” and you find the abstract and commentary for
the randomised controlled trial assessing the prevention of stroke with antihypertensive therapy. The
abstract and commentary look helpful so you decide to go to the library and copy the original article (JAMA
1991;265:3255-64). You make a follow-up appointment with your patient and tell him that you will discuss
the evidence with him at that time.


Read the article and decide,
1. Is the evidence from this randomised trial valid?
2. If valid, is this evidence important?
3. If valid and important, can you apply this evidence in caring for your patient?

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COMPLETED THERAPY WORKSHEET: page 1 of 2

Citation:SHEP Co-operative Research Group. Prevention of stroke by antihypertensive drug treatment in
older persons with isolated systolic hypertension. JAMA 1991;265:3255-3264.

           Are the results of this single preventive or therapeutic trial valid?
           Was the assignment of patients to          Yes
           treatments randomised?
           - and was the randomisation list
           concealed?
           Were all patients who entered the trial    Yes
           accounted for at its conclusion? -and
           were they analysed in the groups to
           which they were randomised?
           Were patients and clinicians kept “blind”  Yes - but may have been some
           to which treatment was being received?     unblinding because more of diuretic
                                                      patients received potassium
                                                      supplements
           Aside from the experimental treatment,     Yes
           were the groups treated equally?

           Were the groups similar at the start of the   Yes - although some slight
           trial?                                        difference between groups in
                                                         limitation of activities of daily living



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Are the valid results of this randomised trial important?

SAMPLE CALCULATIONS

        Occurrence of diabetic              Relative Risk       Absolute Risk   Number Needed
        neuropathy                           Reduction           Reduction         to Treat
                                                RRR                 ARR              NNT
           Usual          Intensive          CER - EER           CER - EER          1/ARR
           Insulin          Insulin             CER
          Control       Experimental
         Event Rate      Event Rate
            CER              EER
            9.6%             2.8%         9.6% - 2.8%       =   9.6% - 2.8% =   1/6.8% = 15 pts,
                                               9.6%                 6.8%
                                                71%




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95% Confidence Interval (CI) on an NNT = 1 / (limits on the CI of its ARR) =




YOUR CALCULATIONS:

                                              Relative Risk     Absolute Risk    Number
                                               Reduction         Reduction      Needed to
                                                  RRR               ARR           Treat
                                                                                  NNT
                CER           EER             CER - EER           CER - EER      1/ARR
                                                 CER
                0.07           0.04      0.7 - 0.04 = 57%            0.03          33
                                             0.07




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COMPLETED THERAPY WORKSHEET: page 2 of 2

       Can you apply this valid, important evidence about a treatment in caring for your
       patient?
       Do these results apply to your patient?
             Is your patient so different from   No, he is similar to those included in the trial
             those in the trial that its results
             can’t help you?


              How great would the potential
              benefit of therapy actually be for
              your individual patient?


              Method I: f                          Risk of the outcome in your patient, relative to
                                                   patients in the trial. expressed as a decimal: 1.0

                                                   NNT/F = 33/1 = 33
                                                   (NNT for patients like yours)
              Method II: 1 / (PEER x RRR)          Your patient’s expected event rate if they
                                                   received the control treatment: PEER:______

                                                  1 / (PEER x RRR) = 1/________ = _______
                                                  (NNT for patients like yours)
       Are your patient’s values and preferences satisfied by the regimen and its consequences?

              Do your patient and you have a       Needs to be assessed in each patient
              clear assessment of their values
              and preferences?



              Are they met by this regimen and     Needs to be assessed in each patient
              its consequences?




Additional Notes:



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HYPERTENSION - THERAPY WITH DIURETICS AND BETA BLOCKERS DECREASES THE RISK OF
STROKE

Clinical Bottom Line:
Treatment of isolated systolic hypertension with diuretics and/or beta blockers decreases the risk of stroke
in the elderly.


Citation: SHEP co-operative research group. Prevention of stroke by antihypertensive drug treatment in
older persons with isolated systolic hypertension. Final results of the systolic hypertension in the elderly
program. (SHEP). JAMA 1991;265:3255-64.


Clinical Question: In a patient with hypertension, will therapy with diuretics decrease the risk of stroke and
death?


Search Terms: "stroke" and "hypertension" in Best Evidence

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The Study:

Double-blinded concealed randomised controlled trial with intention-to-treat.
patients >60 years with isolated systolic hypertension
Control group (N = 2371; 2371 analysed): placebos
Experimental group (N = 2365; 2365 analysed): 4 consecutive steps - chlorthalidone12.5 mg/d; increase to
chlorthalidone 25 mg/d; addition of atenolol 25mg/d or reserpine 0.05 mg/d; increase to atenolol 50mg/d or
reserpine 0.1 mg/d. Goal of therapy was SBP<160 mm Hg and a reduction in SBP of at least 20 mmHg.
Any patient with sustained SBP>220 mmHg or DBP> 90 mmHg was given active treatment.




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The Evidence:

    Outcome      Time to CER               EER     RRR         ARR          NNT
                 Outcome
    Stroke       5 years 0.067             0.044   34%         0.023        43
    95%                                            15% to      0.107 to     28 to 100
    Confidence                                     54%         0.036
    Intervals:
    Deaths       5 years     0.090         0.102   -13%        -0.012       -83
    95%                                            -32% to     -0.029 to    NNT = 209 to INF
    Confidence                                     5%          0.005        NNH = 35 to INF;
    Intervals:




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Comments:

1. Decreased risk of nonfatal MI or coronary heart disease death with treatment (RR 0.73 [0.57 to 0.94]).
2. Only enrolled 1% of the patients that were screened - included the very well elderly and therefore each
   clinician must assess each patient's individual baseline risk and individualise the NNT using this
   estimate.
3. At 5 years, 90% of the study group and 44% of controls were on active treatment and therefore the
   study likely underestimates the benefits of therapy since an intention to treat analysis was done.
4. Was there some unblinding because of the need for some patients(more often the ones receiving
   diuretics) to receive potassium supplements?

Appraised by Straus 1998; Expiry date: 2000




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C. THERAPY (AN ALTERNATE SCENARIO AND ARTICLE)

Clinical Scenario

You are responsible for a geriatric assessment program in your region that involves having people >75
years of age who live at home, seen by a multidisciplinary geriatric team. You are asked by a relative to see
an 80 year old woman who lives by herself in the community and who has refused (on several occasions) to
visit her GP. She has some difficulty with ambulating since she had a stroke 5 years previously. Her family
is concerned because she has noted a decrease in visual acuity and hearing and they have noticed that her
memory has declined. When you visit her, you find she is a very pleasant, independent woman who wants
to know why you are there and how you can help her. You explain that you want to assess her physical and
functional status and social situation because your aim is to help people maintain their independence in the
community. She says “Prove it to me”.
You formulate the question, “In an elderly patient who lives at home, does a comprehensive geriatric
assessment decrease the risk of nursing home admission and improve functional status?” Fortunately, you
have brought your notebook computer with you which has the latest version of Best Evidence on it. You
search Best Evidence using the term “ geriatric assessment” and find an abstract and commentary on an


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article by Stuck et al. which looks promising. (NEJM 1995;333:1184-9). You tell the patient that you will
obtain this article from your office and will return to her with the evidence.


Read this article and decide,
1. Is the evidence from this randomised trial valid?
2. If valid, is this evidence important?
3. If valid and important, can you apply this evidence in caring for your patient?




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COMPLETED THERAPY WORKSHEET: page 1 of 2

Citation: Stuck AE, Aronow HU, Steiner A et al. A trial of annual in-home comprehensive geriatric
assessments for elderly people living in the community. NEJM 1995;333:1184-9.

            Are the results of this single preventive or therapeutic trial valid?
            Was the assignment of patients to          Yes
            treatments randomised?
            -and was the randomisation list
            concealed?
            Were all patients who entered the trial    Yes
            accounted for at its conclusion? -and
            were they analysed in the groups to
            which they were randomised?
            Were patients and clinicians kept “blind”  Interviewers who did the follow-up
            to which treatment was being received?     assessments were blinded

            Aside from the experimental treatment,        Yes
            Were the groups treated equally?

            Were the groups similar at the start of the   Yes
            trial?



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Are the valid results of this randomised trial important?

SAMPLE CALCULATIONS

         Occurrence of diabetic              Relative Risk         Absolute Risk   Number Needed
         neuropathy                           Reduction             Reduction         to Treat
                                                 RRR                   ARR              NNT
            Usual          Intensive          CER - EER             CER - EER          1/ARR
            Insulin          Insulin             CER
           Control       Experimental
          Event Rate      Event Rate
             CER              EER
             9.6%             2.8%        9.6% - 2.8%        =     9.6% - 2.8% =   1/6.8% = 15 pts,
                                              9.6%                     6.8%
                                                71%




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95% Confidence Interval (CI) on an NNT = 1 / (limits on the CI of its ARR) =




YOUR CALCULATIONS: admission to long-term nursing homes

                                              Relative Risk     Absolute Risk    Number
                                               Reduction         Reduction      Needed to
                                                  RRR               ARR           Treat
                                                                                  NNT
                CER           EER           CER - EER             CER - EER      1/ARR
                                              CER
                 .10           .04       58%                          .06          17




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THERAPY WORKSHEET: page 2 of 2

         Can you apply this valid, important evidence about a treatment in caring for your
         patient?
         Do these results apply to your
         patient?
                Is your patient so different from No, this patient is similar
                those in the trial that its results
                can’t help you?


                How great would the potential
                benefit of therapy actually be
                for your individual patient?


                Method I: f                      Risk of the outcome in your patient, relative to
                                                 patients in the trial. Expressed as a decimal:1

                                                 NNT/f = 17/1 = 17
                                                 (NNT for patients like yours)
                Method II: 1 / (PEER x RRR)      Your patient’s expected event rate if they
                                                 received the control treatment: PEER:______

                                               1 / (PEER x RRR) = 1/________ = _______
                                               (NNT for patients like yours)
         Are your patient’s values and preferences satisfied by the regimen and its
         consequences?

                Do your patient and you have     Needs to be assessed in each patient
                a clear assessment of their
                values and preferences?



                Are they met by this regimen     Needs to be assessed in each patient
                and its consequences?




Additional Notes:


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GERIATRIC ASSESSMENT - IMPROVES FUNCTIONAL STATUS AND DECREASES NURSING HOME
ADMISSIONS

Clinical Bottom Line:
Geriatric assessment decreases admissions to long-term nursing homes and improves functional status.


Citation: Stuck AE, Aronow HU, Steiner A et al. A trial of annual in-home comprehensive geriatric
assessments for elderly people living in the community. NEJM 1995;333:1184-9.


Clinical Question: In an elderly patient who lives at home, does a comprehensive geriatric assessment
decrease the risk of nursing home admission and improve functional status?


Search Terms: “geriatric assessment” in Best Evidence




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The Study:

Single-blinded randomised controlled trial without intention-to-treat:
patients >75 years of age who lived at home

Control group (N = 199; 199 analysed): usual care by their physicians
Experimental group (N = 215; 215 analysed): annual assessments in their homes from gerontologic nurse
practitioners-assessments included medical history, physical exam, lab tests; determinations of functional
and mental status, oral health, gait and balance, medications, vision, hearing, social network and support,
home safety and external access.




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The Evidence:

            Outcome      Time to CER        EER     RRR        ARR         NNT
                         Outcome
            Long-term    3 years 0.101      0.042   58%        0.059       17
            nursing
            home
            admission
            95%                                     9% to      0.009 to    9 to 108
            Confidence                              100%       0.109
            Intervals:
            Admission    3 years    0.467   0.460   1%         0.007       143
            to acute
            care
            hospital
            95%                                     -19% to    -0.089 to    NNT =
            Confidence                              22%        0.103       10 to INF
            Intervals:                                                     NNH =
                                                                           11 to
                                                                           INF;


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Comments:
1. Cost of intervention included in this paper but may differ according to your location.
2. These patients had higher education level, lower mortality rate and lower rate of acute care hospital
   admission - therefore need to compare this to your own population to assess applicability.
3. Uncertain which components of the geriatric assessment are the most important and have the greatest
   impact on maintaining independence.

Appraised by Straus 1998; Expiry date: 2000




D. HARM


Clinical Scenario

You see a 73 year old man in your general medicine clinic who has a history of hypertension for which he
has been taking nifedipine XL 30 mg PO per day for 5 years. In his retirement he has learned how to use
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the Internet, and he brings you a print-out of some newspaper headlines that he unearthed while surfing the
net:

LA Times - HYPERTENSION MED KILLS

Washington Post - DRUG FOR BLOOD PRESSURE LINKED TO HEART ATTACKS: RESEARCHERS
FEAR 6 MILLION ARE IMPERILLED

He is very worried and wants to know if he should stop taking nifedipine. Together, you form the clinical
question, “In patients taking calcium antagonists for hypertension, do these calcium antagonists cause
cancer?” You track down the Lancet article referred to in the scary newspaper article (Lancet 1996;348:493-
7).
Read this article and decide,
1. Are the results of this harm study valid?
2. Are the results of this harm study important?
3. Should these valid, important results of this study about a potentially harmful treatment change the
   treatment of your patient?


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COMPLETED HARM/AETIOLOGY WORKSHEET: Page 1 of 2

Citation: Pahor M et al: Calcium-channel blockade and incidence of cancer in aged populations. Lancet
1996;348: 493-97. (also see 487-9 and 541-2)

              Are the results of this harm study valid?
              1. Were there clearly defined groups of Clearly defined, but
                 patients, similar in all important   heterogeneous.
                 ways other than exposure to the      Exposed individuals different from
                 treatment or other cause?            non-exposed (more diabetes and
                                                      cardiovascular disease, disability,
                                                      hospitalisation, but lower diastolic
                                                      pressure), but both groups cancer-
                                                      free at the start of the study.
              2. Were treatment exposures and         Yes. Asked to show their
                 clinical outcomes measured the       medications, and clinical outcomes
                 same ways in both groups (e.g.,      measured the same way in both
                 was the assessment of outcomes       groups.
                 either objective (e.g., death) or
                 blinded to exposure)?
              3. Was the follow-up of study patients Averaged 3.7 years, and long
                 complete and long enough?            enough to show a positive
                                                      relationship between CCBs and
                                                      cancer. But there were only 47
                                                      cancers in 1549 person-years of
                                                      CCB taking.
              Do the results satisfy some “diagnostic
                 tests for causation”?
                      • Is it clear that the exposure Probably; excluded everyone with
                         preceded the onset of the    known cancer at the start (still may
                         outcome?                     have been some smouldering).
                      • Is there a dose-response      Yes (figure 2)
                         gradient?
                      • Is there positive evidence    No
                         from a “dechallenge-
                         rechallenge” study?
                      • Is the association consistent No
                         from study to study?
                      • Does the association make     Whether interference with
                         biological sense?            apoptotic destruction of cancer
                                                      cells is sensible is hotly debated.


BUT: Was this a previously generated hypothesis, or was it one of several analyses carried out on a large
data set of drugs and diseases? (We’ve written to the authors about this and Dr. Pahor has informed us that
this hypotheses was generated prior to the study onset.)

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HARM/AETIOLOGY WORKSHEET: Page 2 of 2


Are the valid results from this harm study important?

                                                     Adverse   Outcome              Totals
                                                  Present          Absent
                                                  (Case)          (Control)
                Exposed to          Yes           3.03%
                   the            (Cohort)                 a    B             a+b
                Treatment           No                     c    D             c+d
                                  (Cohort)        2.17%
                                   Totals                a+c    B+d           a+b+c+d


In this study: Relative Risk = RR = 3.03%/2.17% = 1.4 (P = 0.032) (and when adjusted for several
baseline differences, RR ROSE (!) to 1.7 (P = 0.0005)).

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       Should these valid, potentially important results of a critical appraisal about a harmful
       treatment change the treatment of your patient?
       1. Can the study results be extrapolated to your Depends on whether you believe them. If
          patient?                                      you do believe them, they can be
                                                        extrapolated to your patient.
       1. What are your patient’s risks of the adverse  If we assume our patient is like the
          outcome?                                      average individual in this study (the
                              1
       To calculate the NNH for any Odds Ratio (OR)     hazard ratios are like odds ratios and
          and your Patient’s Expected Event Rate for    don’t differ in important ways between
          this adverse event if they were NOT exposed subgroups), then his Absolute Risk
          to this treatment (PEER):                     Increase in cancer over 3.7 years is
                                                        3.03% - 2.17% = 0.86% = and 1/0.86%
       NNH =         ___PEER (OR - 1) + 1________       gives an NNH of 116.
                         PEER (OR - 1) x (1 - PEER)

       2. What are your patient’s preferences, concerns             Need to be determined.
          and expectations from this treatment?
       3. What alternative treatments are available?                Lots of alternative treatments available
                                                                    for his hypertension (thiazides, beta-
                                                                    blockers). They have their own side-
                                                                    effects but are not reputed to cause
                                                                    cancer.

Additional Notes:
1. Other case-control and cohort studies vary in their conclusions about CCB risks, and a meta-analysis is
   awaited. Until it is sorted out, you could describe NNHs (and possible NNHs) for alternative
   antihypertensive regimens with your patient and the two of you could collaborate in deciding on the most
   appropriate one for him.
1
    The Number of Patients you Need to treat to Harm one of them.



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HYPERTENSION — CALCIUM-CHANNEL BLOCKERS MAY CAUSE CANCER.

Clinical Bottom Line(s):
1. Until this gets sorted out properly, if your patient’s problem could be treated
   as well by some alternative drug (e.g., hypertension), it would be prudent to
   avoid using calcium-channel agents.
2. If this result is true, the NNH to cause one additional cancer from taking
   CCBs for 3.7 years is 116.



Citation: Pahor M et al: Calcium-channel blockade and incidence of cancer in aged populations. Lancet
1996;348: 493-97. (also see 487-9 and 541-2)


Clinical Question: In patients taking calcium antagonists for hypertension, are they at increased risk of
cancer?



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Search terms: from the newspaper headline or from MEDLINE using “calcium antagonists” and “cancer”


The Study:

Total or stratified random samples (>80% response rate) of 65+ y/o men and women in 3 sites in the USA.
Showed their meds, were interviewed 90 minutes, and had their blood pressure, height and weight
measured. Anyone with cancer in previous 3 years or on any cancer Rx was excluded and 94% of the
remainder were followed for an average of 3.7 years by follow-up interview, hospital discharge info and the
national death registry for the occurrence of new cancers.


The Evidence
                                                      Later Cancer                  Totals
                                                 Present        Absent

               Exposed to          Yes            3.03%
                Calcium          (Cohort)                  a B                a+b
                Channel            No                      c D                c+d
                Blockers         (Cohort)         2.17%
                                  Totals                  a+c B+d             a+b+c+d


Relative Risk = RR = 3.03%/2.17% = 1.4 (P = 0.032) (and when adjusted for several baseline differences,
RR ROSE (!) to 1.7 (P = 0.0005)).

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Comments:
1. Individuals on CCBs had more cardiovascular disease, diabetes, disability, and hospitalisations but
   lower diastolic blood pressure. But when they adjusted for all these baseline differences, the RR rose
   rather than fell, suggesting that bias from confounding (of cancer risk and CCB use) of these
   characteristics could not explain these results.
2. There was a dose-response gradient.
3. The difference in risk by type of CCB was impressive but not stat sig (RR 2 for verapamil; 1.5 for
   nifedipine; 0.94 for diltiazem).
4. Only 47 events in CCB takers, and spread over all sorts of different cancers.
5. The proposed mechanism (interference with the apoptotic destruction of cancer cells) pooh-poohed by
   commentators.
6. Other studies of CCBs and mortality go both ways (they’re bad or have no effect), and some authors of
   the former have received anonymous death threats.

Appraised by Sackett 1996, Reviewed 1998, Expiry date 2000




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E. SYSTEMATIC REVIEWS


Clinical Scenario

You are referred a 75 year old man with a stroke who had been admitted one day previously to general
medicine. He has left-sided weakness and has difficulty with ambulating, bathing, feeding and dressing
himself. He has hypertension which is well-controlled with a diuretic. He is otherwise well and you decide to
transfer him to a stroke unit. His family is concerned because they live close to the hospital where he is
currently as an in-patient and want to know why he needs to be transferred to a stroke unit of a different
hospital and why he can’t stay on the general medicine ward. You (with them) formulate the question: “In a
patient with a stroke, does admission to a stroke unit decrease the risk of death and dependency?”


You search Best Evidence using the terms “stroke unit” and “death” and find a promising systematic review.
The abstract and commentary look helpful and you decide to retrieve the complete article. (BMJ
1997;314:1151-9)



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Read the systematic review and decide,
1. Is the evidence from this systematic review valid?
2. Is this valid evidence from this systematic review important?
3. Can you apply this valid and important evidence from this systematic review in caring for your patient?




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COMPLETED SYSTEMATIC REVIEW (of Therapy) WORKSHEET: page 1 of 2

Citation: Stroke unit trialists’ collaboration. Collaborative systematic review of the randomised trials of
organised inpatient (stroke unit) care after stroke. BMJ 1997;314:1151-9.

               Are the results of this systematic review of therapy
               valid?
               Is it a systematic review of           Yes
               randomised trials of the treatment
               you’re interested in?
               Does it include a methods section
               that describes:
                        Finding and including all the       Yes
                        relevant trials?

                      Assessing their individual                 No, but does include
                      validity?                                  characteristics of individual
                                                                 trials

               Were the results consistent from          Consistent results when death is
               study to study?                           the outcome. When death or
                                                         dependency is the outcome, some
                                                         heterogeneity but this was
                                                         explored and seems to reflect the
                                                         nature of the control group i.e. less
                                                         heterogeneity when the stroke unit
                                                         group was compared to a general
                                                         medical unit. There was significant
                                                         heterogeneity in length of stay.


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Are the valid results of this systematic review important?

Translating odds ratios to NNTs. The numbers in the body of the table are the NNTs for the corresponding
odds ratios at that particular patient’s expected event rate (PEER).

                                                            Odds Ratios (OR)
                                   0.9     0.85       0.8   0.75   0.7    0.65    0.6   0.55   0.5
                           .05    2094     139        104    83    69      59     52     46    415
                           .10    110       73         54    43    36      31     27     24    21
             Control       .20     61       40         30    24    20      17     14     13    11
             Event         .30     46       30         22    18    14      12     10      9     8
              Rate         .40     40       26         19    15    12      10      9      8     7
             (CER)        .506     38       25         18    14    11      9       8      7     6
                           .70     44       28         20    16    13      10      9      7     6
                           .90    1017      64         46    34    27      22     18     15    128


4
      The relative risk reduction (RRR) here is 10%
5
      The RRR here is 49%
6
      For any OR, NNT is lowest when PEER = .50
7
      The RRR here is 1%
8
      The RRR here is 9%.


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SYSTEMATIC REVIEW (of Therapy) WORKSHEET: page 2 of 2

      Can you apply this valid, important evidence from a systematic review in caring for
      your patient?
      Do these results apply to your patient?
            Is your patient so different from those in   no
            the systematic review that its results can’t
            help you?
            How great would the potential benefit of
            therapy actually be for your individual
            patient?
            Method I: In the table on page 1, find the   EER and CER provided in Best
            intersection of the closest odds ratio from  Evidence. For death and dependency
            the overview and the CER that is closest     the NNT is 15 (12 to 41)
            to your patient’s expected event rate if
            they received the control treatment
            (PEER):
            Method II: To calculate the NNT for any
            OR and PEER:

                      ___1 - {PEER x (1 - OR)}____
      NNT =           (1 - PEER) x PEER x (1 - OR)
      Are your patient’s values and preferences satisfied by the regimen and its
      consequences?
            Do your patient and you have a clear      Needs to be assessed in each patient
            assessment of their values and
            preferences?


            Are they met by this regimen and its     Needs to be assessed in each patient
            consequences?




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              Should you believe apparent qualitative differences in the efficacy of
              therapy in some subgroups of patients? Only if you can say “yes” to all
              of the following:
              1. Do they really make biologic and clinical sense?
              2. Is the qualitative difference both clinically (beneficial for some but useless
                 or harmful for others) and statistically significant?
              3. Was this difference hypothesised before the study began (rather than the
                 product of dredging the data), and has it been confirmed in other,
                 independent studies?
              4. Was this one of just a few subgroup analyses carried out in this study?


Additional Notes:




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STROKE - STROKE UNITS DECREASE DEATH, DEPENDENCY AND INSTITUTIONALISATION


Clinical Bottom Line:
Stroke units decrease death and dependency, and death and institutionalisation.


Citation: Stroke unit trialists’ collaboration. Collaborative systematic review of the randomised trials of
organised inpatient (stroke unit) care after stroke. BMJ 1997;314:1151-9.


Clinical Question: In a patient with a stroke, does admission to a stroke unit decrease the risk of death and
dependency?


Search terms: “stroke unit” and “death” in Best Evidence



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The Study

Systematic review of RCTs that studied dedicated stroke units, mixed assessment and rehab units or
general medical wards with outcomes of death, dependency or institutionalisation.

The Evidence
19 trials including 3249 patients

                   Outcomes*            CER        EER        RRR                      ARR        NNT (95%
                                        (weighted) (weighted) (95% CI)                 (weighted) CI)
                   death and            .679       .611       9% (16 to                .068       15 (12 to
                   dependency                                 39)                                 41)
                   death and            .475       .377       18% (6 to                0.098      11 (7 to
                   institutionalisation                       28)                                 32)


* Dependency defined as the need for physical assistance with transfers, mobility, feeding, dressing or toileting. Institutionalisation
    included nursing home placement, residential care placement or hospitalisation at the end of the rehab period.

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Comments
1. Mortality rate 21% in the stroke unit and 25% in the general medicine group.
2. Heterogeneity in death or dependency amongst the trials but seems to reflect the nature of the control
   group.
3. Advantages as great in older patients as in younger patients and in those who have had severe stroke
   as in those who have had milder strokes.
4. Little difference in staff numbers or mix or in intensity of rehab provided in organised vs conventional
   care settings but tendency for assessment and treatment to begin earlier in organised settings.
5. Most significant difference were the degree of specialised medical and nursing interest in stroke, staff
   training and involvement of family and caregivers in the rehab process.


Appraised by Straus, 1998; Expiry date 2000.




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